[End] Innovation Forum 2023 "Simplification of pDNA|mRNA Manufacturing Process by Sartorius"

New standards for integrity testing machines that comply with the latest data integrity and QRM.

The Zaltcheck series is the most widely used in the pharmaceutical industry and has gained the trust of many users as a proven integrity testing device. The Zaltcheck 5 Plus is the latest model in the series, released in 2019. With new technology, we have further enhanced usability, compliance with the latest regulations, and error detection capabilities. It sets a new standard for integrity testing devices that meets the needs of customers seeking higher levels of testing. 【Main Features of the Product】 ■ Specifications that exceed QRM legal requirements - Automatic detection of test setting errors and abnormal test conditions ■ Highest level of data integrity - Customized Linux OS - Data encryption and dual data backup ■ Intuitive and excellent operability - Large touchscreen with a clear viewing angle and intuitive user interface - First in the series to support Japanese display ■ Achievement of Health, Safety, and Environment (HSE) - Explosion-proof specifications (ATEX IECEx & FM certified) that allow safe testing of alcohol-wetted filters *For more details, please contact us or download the PDF materials.

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Bioreactor system for cell line development and process optimization.

The Ambr1515 Generation 2 is a high-throughput "automated micro-scale bioreactor system" that reproduces the performance of laboratory-scale bioreactors. The system consists of single-use vessels, an automated workstation, and enhanced convenience software. It is designed to be installed in a standard biosafety cabinet for aseptic operations, allowing for parallel monitoring and control of 24 or 48 micro-bioreactor cultures. As the manufacturing processes for biopharmaceuticals become more complex and the density of cultures increases, scientists around the world are facing an unprecedented challenge in developing "clone, medium, and process" that meet new demands. The Ambr15 Generation 2 system enhances equipment performance that influences the success of cultures, improves flexibility, and incorporates new features that reflect user feedback. It helps address the aforementioned challenges and supports the acceleration of research by scientists.

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Introducing options and accessories that can be added to the Ambr 15 Generation 2.

You can find the following information in this catalog: ▪ System specifications ▪ Compatible at-line analyzers ▪ Expandable options ▪ Accessories ▪ Ambr 15 microbioreactor (culture vessel) ▪ Plates and chips

• Other physicochemical equipment
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Single-use culture equipment that meets the requirements of the microbial culture process.

【Advantages】 ▪ Specifications designed to accommodate all microbial culture processes ▪ Production of plasmid DNA ▪ Microbial culture bags that have undergone qualification for GMP manufacturing ▪ Improved productivity and user-friendly ▪ Refined process control proven in cell culture

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Rapid at-line analysis chromatography solution

【Features】 ▪ High-speed, high-resolution HPLC analysis for pDNA processes ▪ Acceleration of PD and stabilization of manufacturing and quality through at-line monitoring ▪ Ability to obtain a lot of important information in a short time, with low effort and low cost ▪ Unique monolithic column for CIMac pDNA analysis ▪ User guide, dedicated validated methods, SOPs, and standard materials included

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Fully automated tangential flow filtration system using a closed-loop single-use system suitable for process development to pilot-scale manufacturing.

**Features** - Single-use TFF specifically designed for 1 to 20L scale, providing cost-effective solutions from process development to pilot. - Ready-to-use and closed system, resulting in low bio-burden risk. **Characteristics in ADC Manufacturing** - Automation of three processes: ADC synthesis, precipitate removal, and TFF within a single system. - Reduction of funding, labor, installation space, and process risks, enabling a seamless transition from process development to small-scale commercial ADC manufacturing. - Flexible process sequence control allows for compatibility with various ADC manufacturing protocols. - Stirring optimized for minimal capacity with temperature control.

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Technology for clarification of cell cultures and removal of impurities: Sartoclear Depth Filter

The Zaltclear Depth Filter product family is a cellulose-based filter that contains diatomaceous earth. It is used in the biotechnology and pharmaceutical industries, where high solid removal capabilities are required to meet strict standards. In a dual-layer (DL) format, it can filter cell culture media with a cell density of less than 15×10⁶/mL from the process development stage to the commercial production stage.

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Please check the Japanese version catalog for a significant increase in operability and stirring power!

A high-speed, flexible, and intelligent single-use mixer that accommodates all stirring processes in cGMP-compliant bioprocessing. In mixing processes within the bioprocess environment, quality and efficiency are critically important, and the choice of mixing equipment has a dramatic impact on both. A high-speed, flexible single-use mixer enhances manufacturers' competitiveness and improves productivity.

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A robust, complete, and scalable solution for frozen storage and frozen transportation.

Based on over 15 years of experience in the design of single-use freezing and thawing solutions, we have established Celsius pre-design solutions (PDS) for all processes requiring frozen storage and frozen transport, at both lab scale and manufacturing scale. Celsius PDS separates the downstream process and is equipped with the necessary functions for the safe transport of active pharmaceutical ingredients to pharmaceutical manufacturing facilities.

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Smart condition setting, a genuine end-to-end integrated freeze-thaw system.

A robust, complete, and scalable solution for frozen storage and frozen transport. Sartorius offers lab-scale Celsius solutions for smarter and earlier process decisions in the management of frozen active pharmaceutical ingredients. The Celsius Lab-scale Platform enables the characterization of freezing and thawing within single-use bags of 30 mL to 100 mL, featuring complete scalability up to the commercial-scale Celsius Platform (CFT, FFT, and FFTP).

• Other physicochemical equipment
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Freeze-thaw solutions for seamless scalability to commercial production.

Sartorius, with over 15 years of experience in the design of freeze-thaw solutions, offers lab-scale and manufacturing-scale solutions for all steps of processes requiring frozen storage and frozen transport. This enables biopharmaceutical manufacturers to effectively decouple downstream processes and safely transport active pharmaceutical ingredients to drug manufacturing facilities. The Celsius Platform, equipped with options for blast freezers, horizontal freezers, and vertical plate freezers, provides an end-to-end integrated approach that enables monitoring and control to broadly ensure product quality and integrity.

• Other physicochemical equipment
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At Eihon Seiki, we handle Brookfield's rotational viscometers, which are widely used by many customers. We offer consulting services such as measurement method proposals and data analysis to assist our customers with viscometers and rheometers. As part of our ongoing commitment to customer service, we have planned a viscometer user seminar. We will invite Professor Toshiyuki Shikata, an emeritus professor at Tokyo University of Agriculture and Technology, who is active in the field of rheology, to give a lecture covering the basics of viscosity and an introduction to viscoelasticity. There will also be opportunities to ask questions to Professor Shikata and our technical staff regarding any issues or uncertainties you may have in your daily work. We encourage you to consider participating in this opportunity. Seminar Overview: - We will provide an easy-to-understand lecture on the basics of viscosity and viscosity measurement. - We will explain points that can help improve the reproducibility of daily measurements and maintenance within your company. - We will introduce the dispersion of solutions and stability evaluation through live demonstrations. - You will have the opportunity to ask questions directly to Professor Shikata and Eihon Seiki's technical staff.

[Key Lecture Content] 1. The current status of geothermal heat in our country and the Ministry of the Environment's initiatives for its promotion Ministry of the Environment, Water and Air Quality Bureau, Environmental Management Division, Environmental Pollution Control Office Assistant Director Matsui Tatsu 1. About geothermal heat 2. About groundwater heat 3. Utilization for energy conservation 4. Utilization for decarbonization 5. Q&A / Business card exchange 2. Technological trends of geothermal heat pumps and advanced examples from Japan and abroad Non-profit organization Geothermal Utilization Promotion Association Chairman Sasada Masakatsu 1. Overview of geothermal heat pumps and their energy-saving and environmental properties 2. Trends in closed-loop technology 3. Trends in open-loop technology 4. Technological trends of air conditioning systems using geothermal heat as a heat source 5. Future prospects for geothermal heat pumps 6. Q&A / Business card exchange

[Speaker] Cabinet Office, Government of Japan Science and Technology Innovation Promotion Office Planning Officer Takayuki Sato [Key Lecture Content] Japan's AI policy is structured around the fundamental directions of "balancing innovation promotion and risk response" and "international cooperation." In the AI Basic Plan established at the end of last year, we aim to pursue "trustworthy AI" that maintains a human-centered AI society where individual dignity is respected, enabling continuous collaboration between humans and AI. Our goal is to make Japan "the easiest country in the world to develop and utilize AI." This lecture will provide an overview of Japan's AI policies, including examples of initiatives. [Lecture Items] 1. Evolution and development trends of AI 2. Japan's AI policy (background of the AI law enactment, promotion system, etc.) 3. AI-related initiatives (AI Basic Plan, AI guidelines, etc.) 4. Q&A / Business card exchange

In this 5S seminar, we won't just stop at "organizing and tidying up." We will provide plenty of tips on how to utilize 5S as a "visualization of work" and a "tool for discovering waste," evolving the workplace into a more comfortable and productive environment! ✅ Improvement tips you can use starting tomorrow ✅ Engaging and practical exercises and workshops that will inspire and excite you From "doing it because I was told to" to "wanting to take action myself" Your step forward will lead to the evolution of the entire team. This is an opportunity to cultivate a "mindset for improvement" among young employees and enhance the autonomy of the entire organization. From "waiting for instructions" to "thinking and taking action" As you become more accustomed to your work, you will notice the waste and potential that exists. Now, let's gain the "power to change" with 5S! Benefits of 5S: 1. People grow 2. Time becomes more abundant 3. The workplace environment improves 4. 5S does not require significant costs 5. It can be implemented regardless of company size or job type 6. It is appreciated by stakeholders We will teach you the tips to transform 5S from something done because a superior said to do it, or only when there is time, into an enjoyable and sustainable practice. *For more details, please download the PDF or contact us.

This exhibition is one of the largest specialized symposiums in Japan, focusing on fullerenes, carbon nanotubes (CNT), graphene, nanomaterials, advanced materials, functional materials, and two-dimensional materials. Many researchers and engineers involved in material development, device applications, measurement and analysis, research and development, and mass production technology will attend. At our booth, we will introduce products and technological solutions that support research in nanocarbon, advanced material evaluation, device development, and industrial applications from fundamental research. ■ Planned Exhibits - Products from PicoQuant - Ultra-high stability interferometer "GEMINI" (NIREOS) - Superconducting nanowire single-photon detector (SNSPD) (Single Quantum) - Broadband wavelength-tunable laser 400–1000nm SuperK CHROMATUNE (NKT Photonics)